NCT03764722

Brief Summary

Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure. Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

3.4 years

First QC Date

July 26, 2018

Last Update Submit

December 4, 2018

Conditions

Systolic Heart Failure

Keywords

LevosimendanRehospitalisationHeart failure

Outcome Measures

Primary Outcomes (1)

  • Number of rehospitalisations in patients with severe heart failure treated with 24-hour levosimendan infusions

    12 months

Secondary Outcomes (5)

  • Change in quality of life in patients with severe heart failure treated with 24-hour levosimendan infusions.

    from baseline up to 4 weeks during 6 months

  • Change in sodium in patients with severe heart failure treated with 24-hour: SF-36 questionnaire levosimendan infusions.

    from baseline up to 4 weeks during 6 months

  • Change in kaldyum in patients with severe heart failure treated with 24-hour levosimendan infusions.

    from baseline up to 4 weeks during 6 months

  • Change in NT-proBNP in patients with severe heart failure treated with 24-hour levosimendan infusions.

    from baseline and up to 4 weeks during 6 months.

  • Change in troponin T in patients with severe heart failure treated with 24-hour levosimendan infusions.

    from baseline and up to 4 weeks during 6 months.

Study Arms (1)

Levosimendan

EXPERIMENTAL
Drug: Levosimendan

Interventions

LevosimendanDRUG

The patient will initially receive a standard dose of 0.1 mcg/kgmc/min. In case of good tolerance of the drug - the dose will be increased to 0.2 mcg/kgmc/min. If hypotension SBP \<90 mmHg occurs, the dose will be reduced to 0.05 mcg / kgm / min. If the hypotension persists despite the reduction of the drug - the infusion will be terminated and the patient will be excluded from the study. The infusion will be terminated within 24 hours, the patient will be examined again 4 hours after the end of the infusion, by the attending physician and unless there are contraindications - discharged home. Patients will be hospitalized every 4 weeks for the next 6 months.

Levosimendan

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- at least 2 hospitalizations due to exacerbation of chronic heart failure with reduction of left ventricular ejection fraction (EF\< 40%) during last 6 months, despite optimal heart failure treatment

You may not qualify if:

  • chronic kidney disease (GFR \< 30)
  • severe liver damage (AT 5x \> N, bilirubin \>2,0 g/dl)
  • hypotonia
  • hypokalemia
  • HGB\<10g/dl
  • severe aortic and mitral stenosis
  • tachycardia \>100/min or atrial fibrillation with HR \> 120/min
  • features of hypovolemia
  • levosimendan intolerance
  • acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Cardiology

Bydgoszcz, 85-168, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Grzegorz Grześk, Professor

    Collegium Medicum w Bydgoszczy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Małgorzata Dobosiewicz, PhD

CONTACT

48602288918margotd@poczta.onet.pl

Wojciech Hertmanowski, MD

CONTACT

48505518399woj.hertmanowski@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Grzegorz Grześk

Study Record Dates

First Submitted

July 26, 2018

First Posted

December 5, 2018

Study Start

August 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 5, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)